DeviceClearance

K090363

Substantially Equivalent

ZIO PATCH, MODEL Z100

Applicant
iRhythm Technologies, Inc.
Product code
DSH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Francisco, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH
Death
3
Injury
652
Total
655

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.